Safety and privacy issues: ethical vs. practical

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The regulation on the privacy keeps getting stricter, e.g. in some countries it is forbidden to ask for the race of a subject, sometimes only birthdate and sex may be recorded - no initials. Also, the safety of the patients keeps getting stricter, i.e. the inclusion and exclusion criteria are very narrow (e.g. age between 18 and 65, for psychiatric studies: if any familiy member suffers from bipolar disorder, the subject is not allowed in the study...)

Both have as a consequence that it keeps getting harder and harder to reqruite the necessary amount of patients, in order for the study to be statistical relevant. Delays are often the result.

The amount of paperwork that needs to be delivered to the FDA and the IEC is enormous. This costs an afwul lot of energy, manpower and financial power. Which will have reporcussions on the price of the eventual drug.

Finally: it takes, on average, about 15 years until a new drug reaches the market.


The question is: if it takes about 15 years and costs that much energy and effort, is it worth it to invest that money and time? The time-consuming proces of developing a new drug, and keeping the issues of safety and privacy of the subjects in mind, does it weigh up against the fact that people in need are waiting for that drug? What is more important: the protection of the subjects in the study, or being able to help ill people as soon as possible?

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